Platelet Disorder Clinical Trial
Official title:
Towards Improved Diagnostics for Suspected Platelet Function Disorders
Verified date | June 2023 |
Source | Region Stockholm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months and older |
Eligibility | Inclusion Criteria, known defects: - Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay) - High likelihood of platelet function disorder (aberrant screening test with inheritance) - Family investigation for platelet disorder Exclusion Criteria, known defects:: - Antiplatelet or anticoagulant drugs - vWF:GPIb below 0.40 IU/mL - Hematocrit below 0.35 or above 0.50 - Other coagulation disorder Inclusion Criteria, suspected platelet function disorder: - Bleeding investigation at Karolinska University Hospital Exclusion Criteria, suspected platelet function disorder:: - Antiplatelet or anticoagulant drugs - vWF:GPIb below 0.40 IU/mL - Hematocrit below 0.35 or above 0.50 - Other coagulation disorder |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm | Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Platelet count effect on platelet-thrombus formation on collagen surface | Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count < 150 x 10^9 /L. | At study inclusion | |
Other | ddAVP effect on platelet-thrombus formation on collagen surface | Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion). | Immediately before and 1 hour after administration of ddAVP. | |
Other | Thrombus formation on collagen/TF | Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor. | At study inclusion | |
Primary | Platelet-thrombus formation on collagen surface | Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited. | At study inclusion |
Status | Clinical Trial | Phase | |
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